Transcept Pharmaceuticals Receives Complete Response Letter From FDA On Intermezzo R New Drug Application
Transcept Pharmaceuticals (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. In the Complete Response Letter the FDA stated that it believes Transcept has submitted substantial evidence of effectiveness for the use of Intermezzo® in the as-needed treatment of insomnia characterized by difficulty returning to sleep after awakening in the middle of the night.
NECT (Nifurtimox-Eflornithine Combination Therapy), the first new treatment in 25 years against Human African trypanosomiasis (HAT) or sleeping sickness, is now available. Endemic countries have now begun the process of ordering the new combination treatment and kits through the World Health Organization (WHO). Developed by DNDi and its partners, NECT cuts the cost of treatment by half and significantly reduces the burden on health workers. The announcement was made today at the International Scientific Council for Trypanosomiasi Research and Control (ISCTRC), in Kampala, Uganda. "Thanks to an innovative partnership and the hard work of health workers, researchers, and specialists from endemic countries, industry and academia, a new treatment is now available to treat one of the most neglected disease in Africa.
A study in the Nov.1 issue of the journal Sleep shows that sleep deprivation causes some people to shift from a more automatic, implicit process of information categorization (information-integration) to a more controlled, explicit process (rule-based). This use of rule-based strategies in a task in which information-integration strategies are optimal can lead to potentially devastating errors when quick and accurate categorization is fundamental to survival. Results show that sleep deprivation led to an overall performance deficit on an information-integration category learning task that was held over the course of two days. Performance improved in the control group by 4.
A study in the Dec.1 issue of the journal Sleep shows that dream-enacting behaviors are common in healthy young adults, and the prevalence of specific behaviors differs between men and women. Results indicate that 98 percent of subjects (486/495) reported experiencing one of seven subtypes of dream-enacting behavior at least "rarely" in the last year. The most prevalent behavior subtype was "fear, " with 93 percent reporting that they had felt signs of fear in their body after awakening from a frightening dream. Seventy-eight percent reported that they had awakened from an erotic dream to find that they were sexually aroused; 72 percent had awakened from a happy dream to find that they were actually smiling or laughing.
A study in the Nov.1 issue of the journal Sleep shows that retirement is followed by a sharp decrease in the prevalence of sleep disturbances. Findings suggest that this general improvement in sleep is likely to result from the removal of work-related demands and stress rather than from actual health benefits of retirement. Results show that the odds of having disturbed sleep in the seven years after retirement were 26 percent lower (adjusted odds ratio of 0.74) than in the seven years before retiring. Sleep disturbance prevalence rates among 14, 714 participants fell from 24.2 percent in the last year before retirement to 17.8 percent in the first year after retiring.
Sleep apnea is a common disease that affects millions of people all over the world, and if left undiagnosed and untreated can cause serious health complications. GE Sensing & Inspection Technologies (NYSE: GE) has developed the Nova Pressure Amplified (NPA) series of pressure sensors for medical devices. Small and effective, the NPA is a critical component in creating cost-effective sleep apnea monitors that are more accurate and reliable than those currently on the market. "The NPA pressure sensor series ensures that new sleep apnea and respiratory monitors have the best price performance available for critical care and home-use markets, " said Brian Wirth, Global Product Manager at GE Sensing & Inspection Technologies.